A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis

Non-small Cell Lung Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02803619
• Other study ID #: ZS-595
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2016
• Last updated: June 16, 2016
• Start date: November 2013

Study information

• Verified date: June 2016
• Source: Peking Union Medical College Hospital
• Contact: Mengzhao Wang, MD
• Phone: 010-69155039
• Email: mengzhaowang[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).

2. Non-small cell lung cancer patients.

3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.

4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.

5. Expected survival time is greater than 1 month.

Exclusion Criteria:

Patients with radiologic evidence of LM not confirmed by positive CSF cytology.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Leptomeningeal Metastasis
• Lung Neoplasms
• Meningeal Carcinomatosis
• Neoplasm Metastasis
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Department of Respiratory Medicine, Peking Union Medical College Hospita	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival after the diagnosis of leptomeningeal metastasis in NSCLC patients		1 year	Yes